BEUDAMED
    FDA Recall Terminated

    STERRAD 100S Sterilizer (Product Code 10101). The sterilizer includes software and hardware components. The STERRAD Sterilization System is a low-temperature, general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.

    Recall: Z-0340-2009 · Initiated October 17, 2008

    Recall

    Recall Number
    Z-0340-2009
    Event Number
    50073
    Firm
    Advanced Sterilization Products
    FEI Number
    3003662624
    Product Code
    MLR
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    October 17, 2008
    Posted
    November 21, 2008
    Terminated
    November 29, 2011
    Address
    33 Technology Dr, Irvine, CA, 92618

    Description

    STERRAD 100S Sterilizer (Product Code 10101). The sterilizer includes software and hardware components. The STERRAD Sterilization System is a low-temperature, general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.

    Reason

    1) Inability of the sterilizer to detect when an injection takes place without hydrogen peroxide being transferred to the vaporizer bowl. This situation can result in a cycle completion with the injection of insufficient hydrogen peroxide sterilant and 2) Inability of the sterilizer to detect an obstruction in the door travel path while the door is closing. This situation can result in a hand b

    Action

    Customer notifications will be sent the week of November 24, 2008. The notification letter (URGENT: Product Correction) will advise of two situations that could cause the STERRAD 100S Sterilizer to malfunction. The first situation involves the failure of the STERRAD 100S System to detect when an injection takes place without hydrogen peroxide having been transferred to the vaporizer bowl. This can occur under combinations of the following conditions: - the pneumatic pressure is low on the machine, or - the injector valve has a small leak, AND - a cassette fails to advance, or - a used cassette is re-inserted into the sterilizer. This situation can result in a cycle completion with insufficient hydrogen peroxide. The second situation involves the failure of the STERRAD 100S System to detect an obstruction in the door travel path while the door is closing. Under some conditions, the door sensors may become mechanically unsecured/disconnected and will not detect an obstruction. This situation can result in an operator's hand becoming pinched and bruised while the door is closing. To correct both situations above, Advanced Sterilization Products(ASP) has revised the software and is making physical hardware additions to the STERRAD 100S System. Contact ASP Customer Care Center at 888-783-7723, option 2 for questions or assistance.

    Distribution

    Worldwide Distribution including USA and countries of France, Germany, Italy, UK, Switzerland, Benelux, Uruguay, Venezuela, Argentina, Chile, Colombia, Ecuador, Belgium, Puerto Rico, Hong Kong, Indonesia, Mexico, Philippines, Australia, Austria, China, Greece, Israel, Japan, Korea, Malaysia, Singapore, Taiwan, Thailand, Turkey, Middle East, Peru, Canada, Czech Republic, Portugal, South Africa, Spain, Sweden, Hungary, Poland, Brazil, Russia, Egypt, India and Slovenia.

    Quantity

    In the U.S., there are 2,623 units installed. There are also 3,701 units internationally.